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In the Phase 2 portion of the clinical trial, approximately 50 patients are initially planned to receive TC-210 at the RP2D in four distinct cohorts according to their cancer diagnosis: NSCLC, ovarian cancer, malignant pleural/peritoneal mesothelioma and cholangiocarcinoma.
The majority of treatment related adverse events in the Phase 1 trial at RP2D were well-tolerated and grade 1 or 2 in severity.
In the phase 1 part of the study, DEPirinotecan will be administered once every three weeks at escalating doses to characterise the safety, tolerability and pharmacokinetic (PK) profile of DEP irinotecan and to establish the RP2D. In the phase 2 part of the study, patients will be enrolled at the RP2D to generate information on the anti-tumour efficacy of DEP irinotecan in specific tumour types while further characterising the safety, tolerability and pharmacokinetics of the product.
A total of 41 patients have been treated at the RP2D with 3 patients discontinuing prior to 1st scan due to an unrelated treatment-emergent adverse event and patient decision.
The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) in this trial was 24 mg/m2.
In part 2, the safety, tolerability and efficacy of the RP2D of rebastinib in combination with carboplatin administered once every 3 weeks will be assessed across multiple disease cohorts, including: breast cancer, ovarian cancer, and mesothelioma.
The company added the study is designed to evaluate the safety signals, pharmacodynamic modulation and recommended dosage for Phase 2 studies (RP2D).
Part 1 is designed to evaluate the safety, tolerability and pharmacokinetics of 50 mg and 100 mg rebastinib twice daily, or BID, when administered in combination with paclitaxel, and to determine the recommended phase 2 dose, or RP2D, of rebastinib in combination with paclitaxel, in patients with advanced or metastatic solid tumors that are refractory to standard therapies.
In Phase 2 the MTD or RP2D will be administered to 32 patients to evaluate preliminary antitumor activity and to continue to evaluate the safety and tolerability of Onvansertib in combination with standard-of-care chemotherapy.
The MTD or RP2D will be used in the Phase 2 segment of the trial to evaluate antitumor activity and to continue to assess the safety and tolerability of Onvansertib in combination with standard-of-care chemotherapy.
Given the performance of RXDX-105 in that setting, we now look forward to evaluating this investigational agent at the RP2D in targeted patient populations.
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